The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients

Karaman Training and Research Hospital

Status: Completed

Conditions: Intubation Time

Treatments: Procedure: Endotracheal Tube + Video-laryngoscope; Procedure: Endotracheal Tube Alone; Procedure: Endotracheal tube + stylet with Video-laryngoscope; Procedure: Endotracheal Tube+ Stylet

Study type: Interventional

Funder types: Other

Identifiers

NCT05026671

05-2021/04

Details and patient eligibility

About

Although many researchers would agree that obesity per se is not a risk factor for difficult intubation, there are many well known obesity-related challenges in airway management including difficulty with mask ventilation, more frequent and rapid oxygen desaturation, increased oxygen consumption, and increased sensitivity to the respiratory depressant effects of anesthetic and analgesic drugs. Hence, in these conditions, rapid and nontraumatic intubation gain higher interest. There is controversy about using videoaryngoscopy (VL) in obese patients in these difficult situations. The primary aim of this study is to compare, in terms of intubation time, VL,VL plus stylet and direct-laryngoscopy(DL) plus stylet combination with DL alone in obese patients.

Full description

Patients who will be scheduled for surgeries requiring endotracheal intubation, with a body mass index (BMI) more than 30 kg/m2, will be included to this study. During preanesthetic visit (performed by an anesthesiologist not involved in this study) history of difficult intubation, measurement of common predictive indices for difficult intubation (BMI, thyromental distance, neck circumference, Mallampati grade, interincisal [or intergingival] distances), and evaluation of status of dentition and neck movement will be noted.

In the operating room, all patients will be connected to standard monitoring devices. Anesthesia induction will be carried out according to our hospital obese patient anesthesia management protocol. Then, after induction of anesthesia, the patients will be intubated one of four pre-defined protocols that will be determined via randomization during a preanesthetic visit by a person who is unfamiliar with the research protocol.

Primary hypothesis of this study is; using a video-laryngoscope plus stylet will reduce the time required to achieve successful tracheal intubation in obese patients.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with a documented body mass index (BMI) of ≥ 30.
• Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
• Willingness and ability to sign an informed consent document 18 - 80 years of age

Exclusion criteria

• Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
• Patients with a history of facial abnormalities, oral-pharyngeal cancer, or reconstructive surgery
• Emergency surgeries
• Pregnancy
• Any other conditions or use of any medication which may interfere with the conduct of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

Group DL

Active Comparator group

Description:

The control group consists of intubating the trachea with an endotracheal tube alone (without stylet).

Treatment:

Procedure: Endotracheal Tube Alone

Group DLS

Experimental group

Description:

The Experimental group consists of intubating the trachea with an endotracheal tube + stylet.

Treatment:

Procedure: Endotracheal Tube+ Stylet

Group VL

Experimental group

Description:

The Experimental consists of intubating the trachea with an endotracheal tube + Video-laryngoscope

Treatment:

Procedure: Endotracheal Tube + Video-laryngoscope

Group VLS

Experimental group

Description:

The Experimental consists of intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope

Treatment:

Procedure: Endotracheal tube + stylet with Video-laryngoscope